1017960 HealthFirst Mail-In Spore Testing Service, 12 Test

Basic Information

• Brand Name: 1017960 HealthFirst Mail-In Spore Testing Service, 12 Test
• Primary DI: M985HFY120
• Version / Model: HF-Y12
• Catalog Number: HF-Y12
• Company Name: MESA LABORATORIES, INC.
• Labeler DUNS: 102530326
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2024-12-18
• Public Version: 1
• Public Version Date: 2024-12-26
• Public Version Status: New
• Public Device Record Key: be6f5e2b-5764-42d8-98d6-458b31cb0103

Device Description

Private label MIST product

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRC	Indicator, Biological Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M985HFY120	HIBCC
Unit of Use	M985HFY12	HIBCC